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GUIDANCE DOCUMENT

E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES July 2019

Draft

Not for implementation. Contains non-binding recommendations.

This guidance is being distributed for comment purposes only.

Submit Comments by

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2019-D-3049


Docket Number:
FDA-2019-D-3049
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

Clinical studies of medical interventions are conducted to provide information that can ultimately improve access to safe and effective drugs with meaningful impact on patients, while protecting those participating in the studies. This document focuses on designing quality into clinical studies, considering the diversity of clinical study designs and data sources used to support regulatory and other health policy decisions.